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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE Back to Search Results
Model Number V173
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited functionality. Boston scientific technical services recommended device replacement. At this time, this crt-p device remains in service. No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited functionality. Boston scientific technical services recommended device replacement. At this time, this crt-p device remains in service. No adverse patient effects were reported. This supplemental report is being filed as surgical intervention was performed as this cardiac resynchronization therapy pacemaker (crt-p) was explanted and returned for device analysis. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed. Interrogation of the device confirmed it was operating in safety mode due to system resets. It was confirmed that brady therapy remained available. The system resets occurred during a telemetry session and caused the device to enter safety mode. Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery. The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation. Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior. This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
 
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Brand NameINVIVE
Type of DeviceIMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key11356112
MDR Text Key232928129
Report Number2124215-2021-02931
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/17/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/20/2021 Patient Sequence Number: 1
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